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Your search for “patent exclusivity” returned the following results.
…not impose a 30-month stay of approval on an ANDA as to which the NDA holder or patent owner has initiated patent litigation as a result of the ANDA applicant’s…
…5, 2009 is derived from QI Act § 4(b), which includes three transition provisions on Orange Book patent listing, certification, and 180-day exclusivity for each ANDA applicant that not later…
…holder or patent owner may choose to sue a generic applicant for patent infringement if the generic applicant submits an ANDA containing a Paragraph IV certification to an Orange Book-listed…
…exclusivity is listed in the Purple Book yet, Semglee should be eligible for 12 months of exclusivity, which would block FDA licensure of any subsequent interchangeable biosimilars starting from its…
…exploiting their patents and statutory exclusivity to stifle competition and maintain a monopoly. The Plan advocates better cross-agency efforts between the Food and Drug Administration (“FDA”) and the Federal Trade…
…input on a broad range of BPCI Act topics, including biosimilarity, interchangeability, patient safety and pharmacovigilance, exclusivity, and user fees. FDA’s notice follows an announcement from earlier this year after…
…presently fit for judicial review. AstraZeneca may have its own views as to the scope of its new patient population exclusivity and the relationship between that exclusivity and ANDAs submitted…
…drugs, and because the biotechnology industry is considerably less mature, Congress should enact special provisions—such as additional patent life or data exclusivity protections—that will help the industry remain viable. Indeed,…
…Novartis has a right of reference. A section 505(b)(2) supplement would require appropriate patent and exclusivity certifications, and approval of such supplement could be delayed by patent or exclusivity protections….
…on FDA’s previous licensure of an innovator’s product. In addition, the bill provides a 12-year period of innovator marketing exclusivity, limited “generic” exclusivity under certain circumstances, and patent resolution provisions. …
…a patent on the reference product may sue a biogeneric applicant for patent infringement. Under certain circumstances, such litigation could delay the approval of the biogeneric product. The draft bill…
…exclusivity is broad; it prevents FDA approval of ANDAs, “full” 505(b)(1) NDAs, and 505(b)(2) applications. Orphan drug exclusivity begins on the date that a marketing application is first approved for…
…agreed to share its profits with certain generic competitors – one of whom already has ANDA approval and is eligible for 180-day exclusivity – provided they would not launch their…
…of exclusivity under [FDC act § 505A].” (Neither version of the bill takes into account the new pediatric exclusivity provisions for biological products under new PHS Act § 351(m).) Added…
…already approved for the orphan use, either where the approved drug received orphan-drug exclusive approval (even after such drug’s exclusivity period has run out) or where the approved drug was…